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Allergic Asthma Due to Dermatophagoides FarinaePhase 3MAPITNCT03654976

Mite Asthma Pediatric Immunotherapy Trial

A Phase 3 study testing HDM SLIT-tablet in people with Allergic Asthma Due to Dermatophagoides Farinae and Allergic Asthma Due to Dermatophagoides Pteronyssinus, run by ALK-Abelló A/S at 64 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening. Read more about this study

Who is it for?
Ages 5 to 17 years
What is being tested?
HDM SLIT-tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
533 participants
Where
64 sitesin 9 countries
Study dates
22 Feb 2018to 31 May 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Written informed consent
  • Male or female of any race/ethnicity aged 5-17 years
  • A female subject of childbearing potential must have a negative pregnancy test and be willing to practise appropriate contraceptive methods
  • A clinical history of HDM allergic asthma
  • Use of low daily dose of ICS plus LABA or medium/high daily dose of ICS with or without LABA for the control of asthma symptoms
  • A clinical history of asthma exacerbations in the past two years
Show all 17Show fewer
  • One or more of the following within the past 4 weeks prior to randomisation:
  • Daytime asthma symptoms more than twice/week
  • Any nocturnal awakening due to asthma
  • SABA rescue medication needed for treatment of asthma symptoms
  • Any activity limitation due to asthma
  • Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements
  • Clinical history of HDM AR within the last year prior to randomisation
  • An average TCRS>0 during the baseline period
  • Positive specific IgE (defined as ≥class 2, ≥0.70 kU/l) against D. pteronyssinus and/or D. farinae at screening
  • Positive SPT to D. pteronyssinus and/or D. farinae at screening
  • Subject willing and able to comply with trial protocol

Who cannot join

  • Is sensitised and regularly exposed to animal dander, molds, and/or cockroach or other perennial allergen
  • Has experienced a life-threatening asthma attack
  • Within the last month before the randomisation visit (visit 3), has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
  • Within the last 3 months before the randomisation visit (visit 3) while on high dose ICS treatment, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
  • Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
  • Ongoing treatment with any allergy immunotherapy product
Show all 19Show fewer
  • Any clinically relevant condition or chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject
  • Has a diagnosis of eosinophilic oesophagitis
  • A relevant history of systemic allergic reactions
  • Ongoing treatment with OCS
  • Treatment with restricted and prohibited concomitant medication
  • Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
  • A history of allergy, hypersensitivity or intolerance to any of the excipients or active substance of the IMP (except D. pteronyssinus and D. farinae) or to any excipient of the rescue medication provided in this trial
  • A business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial
  • A history of alcohol or drug abuse
  • Has previously been randomised into this trial, is participating in this trial at another investigational site or is participating or planning to participate in any other clinical trial during the duration of this trial
  • Has a history or current evidence of any condition, treatment, laboratory values out of range or other circumstance that in the opinion of the investigator are clinically relevant and might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial
  • Has a condition or treatment that increase the risk of the subject developing severe adverse reactions after adrenaline/epinephrine administration
  • Is unable to or will not comply with the use of adrenaline/epinephrine auto-injectors for countries where this is a regulatory requirement

Trial locations and contacts

64 sites in 9 countries.

64 sites in 9 countries

Poland15 sites

  • NZOZ E-Vita

    Bialystok

  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

    Bialystok

  • Specjalistyczna Praktyka Lekarska

    Katowice

  • Centrum Medyczne PROMED

    Krakow

  • Centrum Nowoczesnych Terapii

    Krakow

  • WWCOiT

    Lodz

  • ALERGOTEST s.c. Specjalistyczne Centrum Medyczne

    Lublin

  • Uniwersytecki Szpital Dzieciecy w Lublinie

    Lublin

  • Ostrowieckie Centrum Medyczne S.C.

    Ostrowiec Świętokrzyski

  • Prywatny Gabinet Lekarski

    Rzeszów

  • NSZOZ Puls

    Skarżysko-Kamienna

  • ETG Skierniewice

    Skierniewice

  • ALERGO-MED Specjalistyczna

    Tarnów

  • Dobrostan

    Wroclaw

  • Specjalist.

    Zabrze

Other trials in Poland

Russia11 sites

  • Kazan State Medical University 138

    Kazan'

  • First Moscow State Medical University

    Moscow

  • Clinical and Diagnostic Centre "Zdorovie"

    Rostov-on-Don

  • Rayzan Regional Children Hospital

    Ryazan

  • City children's polyclinic #35

    Saint Petersburg

  • GBUZ "Children Municipal Polyclinic #45"

    Saint Petersburg

  • LLC ArsVite Severo-Zapad

    Saint Petersburg

  • LLC Kurator

    Saint Petersburg

  • GBUZ "Samarskiy oblastnoy detskiy sanatoriy "Yunost" 9-proseka

    Samara

  • LLC 'ArsVitae Samara'

    Samara

  • Siberian State Medical University

    Tomsk

Other trials in Russia

Bulgaria8 sites

  • MHAT

    Plovdiv

  • UMBAL "St. Georgy"

    Plovdiv

  • SHATPPD

    Rousse

  • Medical Center-1-Sevlievo EOOD

    Sevlievo

  • Alitera-Med-Medical Center EOOD

    Sofia

  • MBAL Tokuda Hospital Sofia

    Sofia

  • Medical Center Excelsior

    Sofia

  • DCC Ritam 2010

    Stara Zagora

Other trials in Bulgaria

United States7 sites

  • Private Clinic

    Bangor, Pennsylvania, 04401

  • TTS research

    Boerne, Texas, 78006

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Miami Clinical Research

    Miami, Florida, 33155

  • STAAMP Research

    San Antonio, Texas, 78251

  • Allergy Consultants

    Verona, Pennsylvania, 07044

  • Respiratory Medicine Research Institute of MI

    Ypsilanti, Michigan, 48197

Other trials in United States

Spain7 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona

  • Hospital Universitario Vall d'Hebrón

    Barcelona

  • Hospital Regional Universitario de Málaga

    Málaga

  • Hospital de Sagunto

    Sagunto

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Hospital de Conxo

    Santiago de Compostela

  • Hospital de la Plana

    Villarreal

Other trials in Spain

Hungary6 sites

  • Bajai Szent Rókus Kórház

    Baja

  • Heim Pal Children's Hospital

    Budapest

  • Semmelweis Egyetem

    Budapest

  • Kanizsai Dorottya Korhaz

    Nagykanizsa

  • Szent István Rendelő és Patika

    Ráckeve

  • Aranyklinika Kft

    Szeged

Other trials in Hungary

France5 sites

  • Hopital Augustin Morvan

    Brest

  • Centre Hospitalier Universitaire de Caen

    Caen

  • Centre hospitalier intercommunal

    Créteil

  • Hôpital Jeanne de Flandre

    Lille

  • Groupe hospitalier Armand Trousseau - La Roche Guyon

    Paris

Other trials in France

Germany3 sites

  • Kinderarzt-Praxis Bramsche

    Bramsche

  • Kinderarztpraxis Ludwigsfelde

    Ludwigsfelde

  • Kinderarztpraxis

    Wuppertal

Other trials in Germany

United Kingdom2 sites

  • Royal Manchester Children's Hospital - Paediatrics Oxford Road

    Manchester

  • Southampton General Hospital

    Southampton

Other trials in United Kingdom

About this study

Official title: A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Children and Adolescents (5-17 Years) With HDM Allergic Asthma

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.

Read the detailed description

The trial aims to demonstrate efficacy of the HDM SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with HDM allergic asthma based on clinically relevant asthma exacerbations.

Additionally, the trial will investigate if the treatment has an effect on asthma symptoms including nightly awakenings due to asthma, asthma medication use, asthma control, lung function, allergic rhinitis and allergic rhinoconjunctivitis.

Finally, quality of life (QoL) for subjects and caregivers will be measured.

The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 2 years. Subjects will receive a written asthma action plan.

Being tested
HDM SLIT-tablet, Placebo
Keywords
Allergic asthma, allergic rhinitis, HDM, pediatric
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HDM SLIT-tabletBiological

    Also called Acarizax, Odactra

    Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)

  • PlaceboOther

    Placebo sublingual tablet, for daily administration (1 tablet per day)

Study groups in NCT03654976
Study groupRoleWhat they receive
Active treatmentExperimentalSubject's ICS or ICS/LABA background medication plus HDM SLIT-tablet
Receives: Biological: HDM SLIT-tablet
PlaceboPlacebo comparatorSubject's ICS or ICS/LABA background medication plus placebo oral tablet
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Rate of Clinically Relevant Asthma Exacerbations

    The primary endpoint of the trial was the annualized rate of clinically relevant asthma exacerbations calculated as the number of exacerbations per year per participant during the efficacy evaluation period of 20 months. A clinically relevant asthma exacerbation had to be medically confirmed and was defined as asthma worsening leading to at least 1 of the following criteria:

    • Doubling of ICS dose compared to background treatment
    • Systemic corticosteroids for treatment of asthma symptoms for at least 3 days
    • Emergency room visit due to asthma, requiring systemic corticosteroids
    • Hospitalization for more than 12 hours due to asthma, requiring treatment with systemic corticosteroids

    The outcome measure (by treatment group) is an adjusted annualized rate of clinically relevant asthma exacerbations.

    Measured: Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)

Secondary outcomes (5)

  1. Proportion of Days With Nocturnal Awakenings Due to Asthma Requiring SABA Rescue Medication

    The days with nocturnal awakenings due to asthma requiring SABA rescue medication were entered in an eDiary by the participant/caregiver in a 2-week period every 4 months. The proportion of days with nocturnal awakenings due to asthma requiring SABA was presented on a range from 0 to 1 (1 indicating that all days in the eDiary period were with nocturnal awakenings due to asthma requiring SABA rescue medication). The efficacy assessment was based on data collected over the 20 months efficacy assessment period.

    The outcome measure (by treatment group) is an estimated proportion of days with nocturnal awakenings due to asthma requiring SABA rescue medication.

    Measured: Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)

  2. Proportions of Days With SABA Use

    The days with SABA use were entered in an eDiary by the participant/caregiver in a 2-week period every 4 months. The proportion of days with SABA use was presented on a range from 0 to 1 (1 indicating that all days in the eDiary period were with SABA use). The efficacy assessment was based on data collected over the 20 months efficacy assessment period.

    The outcome measure (by treatment group) is an estimated proportion of days with SABA use.

    Measured: Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)

  3. Percentage Predicted FEV1

    The outcome measure (by treatment) is an average of the percentage predicted FEV1 measured at visits 5 to 11 (every 4 months during the 20 months efficacy assessment period), analyzed using MMRM (mixed-effect model repeated measurement).

    FEV1 (forced expired volume in 1 second) is assessed by use of spirometry and is a measure for lung function. Percentage predicted FEV1 is derived from the predicted FEV1, which is the expected value of FEV1 for a person of a certain age, race, height and gender with healthy lungs.

    Measured: Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)

  4. Global Evaluation of Allergic Asthma as Having an Improved Outcome

    At the end of trial visit, the subject was asked, when compared to their asthma before IMP treatment, how they felt overall. Subjects who answered 'much better' or 'better' were categorized as having improved allergic asthma. At the end of trial visit, subjects had been treated for 24-30 months (including a 4-10 months treatment initiation and maintenance period).

    The outcome measure (by treatment) is an adjusted odds of experiencing improved allergic asthma.

    Measured: Assessment done at the end of trial visit (after 24-30 months of treatment)

  5. Global Evaluation of Allergic Rhinitis as Having an Improved Outcome

    At the end of trial visit, the subject was asked, when compared to their rhinitis before IMP treatment, how they felt overall. Subjects who answered 'much better' or 'better' were categorized as having improved allergic rhinitis. At the end of trial visit, subjects had been treated for 24-30 months (including a 4-10 months treatment initiation and maintenance period).

    The outcome measure (by treatment) is an adjusted odds of experiencing improved allergic rhinitis.

    Measured: Assessment done at the end of trial visit (after 24-30 months of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start22 Feb 2018
  3. Primary completion18 May 2022
  4. Study completion31 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel-group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
533 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03654976
Sponsor's protocol ID
MT-11
Other IDs
2016-004363-39, 2016
Acronym
MAPIT
Status last verified
Oct 2023
First submitted
24 Aug 2018
Last updated
19 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roberts G, Just J, Nolte H, Hels OH, Emeryk A, Vidal C. SQ House Dust Mite Sublingual Immunotherapy Tablet in Children With Allergic Asthma: A Randomised Phase III Trial. Allergy. 2025 Dec;80(12):3401-3411. doi: 10.1111/all.70073. Epub 2025 Oct 9.

    PubMed 41064908

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HDM SLIT-tablet in people with Allergic Asthma Due to Dermatophagoides Farinae and Allergic Asthma Due to Dermatophagoides Pteronyssinus, run by ALK-Abelló A/S at 64 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Poland, Russia, Bulgaria, United States, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Rate of Clinically Relevant Asthma Exacerbations (time frame: Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03654976, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.

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